Counterfeit Ozempic Once Again Found in the U.S. Supply Chain

Counterfeit Ozempic Label

Ozempic: Back in the News

In what has become a sad yet true frequent occurrence, counterfeit Ozempic has once again been found in the U.S. supply chain.

On April 3rd, 2025 the FDA was notified by Novo Nordisk that several hundred units of counterfeit Ozempic (semaglutide) injection 1mg were distributed outside of their authorized supply chain. Nonetheless, these drugs have ended up in the hands of either patients, wholesalers, retail pharmacies, and/or healthcare professionals, with the FDA seizing a few identified counterfeit products on April 9th, 2025.

The FDA advises associated parties to check Ozempic products carefully, and to not use, distribute, or sell those with the lot number PAR0362 and serial numbers beginning with 51746517. Products within lot number PAR0362 that do not contain serial numbers beginning with 51746517 are still legitimate.

A Common Theme

Semaglutide and other Glucagon-like-Peptide-1 (GLP-1) medications have become popular for their treatment of type-2 diabetes, obesity, and cardiovascular complications. Their popularity has resulted in product shortages, further incentivizing counterfeiters and channel-diverters to manufacture counterfeit goods that put pharmaceutical vendors and their patients at risk.

When product is deemed potentially counterfeit, manufacturers launch investigations, impose quarantines, and destroy product to prevent these products from infiltrating the legitimate supply chain. The U.S. Code of Federal Regulations states that when a pharmaceutical manufacturer cannot differentiate between good and bad product, the entire returned shipment must be destroyed. However, quarantining and destroying highly-demanded products (like Ozempic) further contributes to the shortage issue if these products are legitimate.

The Importance of VRS Systems in Action

Product verification through Verification Router Service (VRS) systems alleviate this problem, helping pharmaceutical vendors quickly identify counterfeit goods. By facilitating the request for verification of the product identifier applied to a serialized product, VRS systems accurately pinpoint the source of product in seconds, confirming product came from a certified manufacturer and is suitable for subsequent commerce.

It’s hard to differentiate between a legitimate and counterfeit product without VRS systems. As a buyer of product, you can confirm the lot number, expiration date, and GTIN are all legitimate; however, it’s hard to tell if a serial number is legitimate without confirmation from the manufacturer. That’s where VRS systems come in.

VRS Systems are an efficient solution to preventing illegitimate product from entering the supply chain, while also preventing legitimate product from mistakenly being discarded or quarantined. Their continued implementation and widespread use will simplify product verification, prevent unnecessary shortages, and make our supply chains safer.

Unguessable Serialization

This instance of counterfeiting also demonstrates another major issue: consecutive serialization. As demonstrated by the above image, the FDA was able to conclude that potential counterfeits all begin with the same lot number, PAR0362, and contain serial numbers beginning with 51746517.

With consecutive serialization, counterfeiters are more easily able to guess which serial numbers occur next in the sequence. When serial numbers are randomized, non-sequential, they become unguessable and difficult to counterfeit.

Randomized serial numbers make it impossible for counterfeiters to identify a pattern when generating new, illegitimate serial numbers. Reverse-engineering from a genuine product becomes useless, as that single data point provides no reliable way to create other valid serial numbers.

Checking Serialized Product Identifiers

Lastly, continually checking the serialized product identifier as product travels throughout the supply chain ensures detection of counterfeit or diverted product before it reaches patients. In the absence of distributors scanning serialized product identifiers, counterfeit or diverted product can seep into the legitimate supply chain.

As identified in this instance, the importance of VRS Systems, unique serialization, and checking serialized product identifiers cannot be overlooked. Stop guessing and start checking.

Visit our website to learn more: https://gatewaychecker.com/

What Isn’t Included in the Recent Exemption

Who Does It Apply To?

Recently, I shared that eligible trading partners were temporarily exempted from specific components of the Drug Supply Chain Security Act, “Latest DSCSA Exemption”. However, considering the stabilization period ends tomorrow, I thought I’d share some further insights on what isn’t part of the recent exemption.

First, as noted in my previous posts, the recent exemption doesn’t apply to everyone. As the FDA emphasized in their release, trading partners who are eligible for the exemption include “those who have initiated their systems and processes by successfully completing data connections with their immediate trading partners”, and “those who initiated processes including documentation of efforts to establish data connections but were not able to fully complete them with all immediate trading partners.” In other words, now is not time for trading partners to start initiating their systems and processes (that ship has sailed)—it’s time for trading partners to refine them.

Progress Necessary

The FDA wants to see progress made toward finalizing systems and processes capable of exchanging DSCSA transaction information and transaction statements with one another. Key enablers of this progress include:

  • Reconciling receipts of digital and physical representations of Serialized Information
  • Investigating suspect process
  • Verifying product for saleable returns
  • Responding to a trace request

In addition to documentation of progress, the FDA expects trading partners who plan to rely on the extension to communicate their intentions with immediate trading partners.

The FDA, similarly to when they announced their decision to implement the stabilization period, does not want trading partners to view this exemption as a “justification for delaying efforts to implement enhanced drug distribution security requirements.”

The deadline for compliance will come sooner than many expect, especially for manufacturers. In fact, there are only 129 working days until the May 27th, 2025 EDDS deadline.

Risks of Noncompliance

For those who haven’t initiated these systems and processes, punishments could be severe, and include:

  • Regulatory Risks: Potential for regulatory actions like warning letters, import alerts, or product seizures.
  • Operational Disruptions: Potential for supply chain disruptions and delays in product acceptance.
  • Market Exclusion: Risk of being completely excluded from the supply chain

Partners who do not meet the exemption criteria will need to submit a Waiver, Exception, or Exemption, or will more than likely face the consequences outlined above.

Stabilization Behind Us

Navigating DSCSA compliance amidst the constant changes to legislation can be tricky. However, one thing is for sure: if your business lacks systems and processes in place to implement EDDS requirements, the business is at risk.

With stabilization behind us, let Gateway Checker put you on the fast path towards supply integrity and regulatory compliance. Visit our website to view our services, or contact our team with any questions.

What Is Exempt, per recent DSCSA Update 

According to the DSCSA Exemption Announcement from the FDA on October 9th, here are the specific components of the legislation that eligible trading partners are exempt from. 

Section 582(g)(1)(A-F) for Manufacturers and Repackagers, Wholesale distributors, and Dispensers 

‘‘(A) The transaction information and the transaction statements as required under this section shall be exchanged in a secure, interoperable, electronic manner in accordance with the standards established under the guidance issued pursuant to paragraphs (3) and (4) of subsection (h), including any revision of such guidance issued in accordance with paragraph (5) of such subsection. 

‘‘(B) The transaction information required under this section shall include the product identifier at the package level for each package included in the transaction. 

‘‘(C) Systems and processes for verification of product at the package level, including the standardized numerical identifier, shall be required in accordance with the standards established under the guidance issued pursuant to subsection (a)(2) and the guidances issued pursuant to paragraphs (2), (3), and (4) of subsection (h), including any revision of such guidances issued in accordance with paragraph (5) of such subsection, which may include the use of aggregation and inference as necessary. 

‘‘(D) The systems and processes necessary to promptly respond with the transaction information and transaction statement for a product upon a request by the Secretary (or other appropriate Federal or State official) in the event of a recall or for the purposes of investigating a suspect product or an illegitimate product shall be required. 

‘‘(E) The systems and processes necessary to promptly facilitate gathering the information necessary to produce the transaction information for each transaction going back to the manufacturer, as applicable, shall be required—  

‘‘(i) in the event of a request by the Secretary (or other appropriate Federal or State official), on account of a recall or for the purposes of investigating a suspect product or an illegitimate product; or 

‘‘(ii) in the event of a request by an authorized trading partner, in a secure manner that ensures the protection of confidential commercial information and trade secrets, for purposes of investigating a suspect product or assisting the Secretary (or other appropriate Federal or State official) with a request described in clause (i). 

‘‘(F) Each person accepting a saleable return shall have systems and processes in place to allow acceptance of such product and may accept saleable returns only if such person can associate the saleable return product with the trans- action information and transaction statement associated with that product. 

Section 582(c)(4)(D) For Wholesale Distributors 

(D) VERIFICATION OF SALEABLE RETURNED PRODUCT: Beginning 6 years after the date of enactment of the Drug Supply Chain Security Act, upon receipt of a returned product that the wholesale distributor intends to further distribute, before further distributing such product, the wholesale distributor shall verify the product identifier, including the standardized numerical identifier, for each sealed homogeneous case of such product or, if such product is not in a sealed homogeneous case, verify the product identifier, including the standardized numerical identifier, on each package.

Section 582(d)(4)(A)(ii)(II) and (B)(iii) for Dispensers with 26 of more full-time employees* 

‘‘(II) Dispenser must promptly conduct an investigation in coordination with trading partners, as applicable, to determine whether the product is an illegitimate product beginning 7 years after the date of enactment of such Act, verifying that the product identifier, including the standardized numerical identifier, of at least 3 packages or 10 percent of such suspect product, whichever is greater, or all pack- ages, if there are fewer than 3, corresponds with the product identifier for such product 

‘‘(iii) RESPONDING TO A NOTIFICATION —Upon the receipt of a notification from the Secretary or a trading partner that a determination has been made that a product is an illegitimate product, a dispenser shall identify all illegitimate product subject to such notification that is in the possession or control of the dispenser, including any product that is subsequently received, and shall perform the activities described in subparagraph (A). 

*Recall that an exemption was given to dispensers with 25 or less full-time employees already until November 27th, 2026. This is one year after the dispensers with 26 or more full time employees. 

For any questions regarding the exemption, feel free to contact the Gateway Checker team 

 

 

 

 

 

DSCSA Exemptions from Section 582 and Other Requirements of the FD&C Act for Certain Trading Partners

The FDA announced on October 9th that they are granting eligible pharmaceutical trading partners exemptions from Enhanced Drug Distribution Security (EDDS) requirements of the FD&C Act. Eligible trading partners include those who have initiated systems and processes and successfully completed data connections with immediate trading partners, or those who have initiated processes (with documentation) to establish data connections, but were unable to fully complete them with all of their immediate trading partners, by November 27th, 2024.

Specifically, eligible trading partners will be exempt from key portions of Section 582 of the FD&C Act. These exemptions and their respective sections of the FD&C include:

  • Enhanced drug distribution requirements– section 582(g)(1)
  • Verification requirements for wholesale distributors concerning saleable returned product– section 582(c)(4)(D)*
  • Verification requirements for dispensers concerning illegitimate or suspect product– sections 582(d)(4)(A)(ii)(II) and (d)(4)(B)(iii)**

*Eligible wholesale distributors are still obligated to meet all other verification requirements of section 582(c)(4) of the FD&C Act, including package-level product verification to investigate suspect/illegitimate product.

**Eligible dispensers are still obligated to meet all other verification requirements of section 582(d)(4) of the FD&C Act, including package-level product verification to investigate suspect/illegitimate product.

The FDA has implemented these exemptions based on pharmaceutical trading partner feedback. Particularly, trading partners have described challenges resolving issues related to missing or erroneous data in electronic DSCSA transactions, without delaying drug movement downstream. This, partners have argued, could contribute to drug shortages and prevent pharmacies and patients from receiving the drugs they need.

These exemptions vary in length based on trading partner type:

  • Manufacturers and Repackagers: May 27, 2025
  • Wholesale Distributors: August 27, 2025
  • Dispensers with 26 or more full-time employees: November 27, 2025

It will be interesting to see how these exceptions are enforced, and how eligible trading partners will be identified:

  1. What “documentation of evidence to establish data connections” will make a trading partner exempt?
  2. How will the FDA ask for this “documentation”, and how will they check for progress?
  3. What will this mean for those who haven’t made efforts to comply?

HDA DSCSA Guidance

Following the recent HDA Traceability Seminar between August 26th-28th, I had the opportunity to lead a conversation amongst dozens of pharmaceutical partners and solution providers; we discussed various important topics related to the DSCSA, from Waiver, Exception, and Exemptions, to Verification Routing Services, and more. Emphasizing the importance of transparency and open conversation, I thought I’d highlight some important insights.  

It’s All About the Data

The FDA understands there are conflicts in terms of data quality and integrity. Downstream integrity is impossible without manufacturers ensuring their data and products align with updated standards. The FDA has stressed the importance of pharmaceutical partners, particularly manufacturers, meeting these standards by the end of the stabilization period (next month). However, for certain exceptions, including product/no data, WEEs must be considered.  

Waivers, Exceptions, Exemptions

Since mid-June, there have been over 324 requests for package-level requirements WEEs, with more likely to be submitted as we approach the deadline. Dispensers are most frequently requesting WEEs, followed by wholesalers, manufacturers, and repackages. The issue many partners are experiencing is that downstream partners cannot get accurate data from suppliers without upstream partners providing it to them efficiently. The FDA believes it is adequately staffed to handle WEEs, and if they find consistent requests for handling WEE scenarios, they will announce how partners should handle them.  

Easier Said than Done

Navigating the complexities of Waivers, Exceptions, and Exemptions is oftentimes easier said than done. While the FDA has provided various recommendations for handling tricky exceptions, oftentimes, partners still find themselves facing challenges in practice.  

VRS on the Rise

VRS is gaining popularity as an effective means to ensure interoperability between supply chain partners, helping pharmaceutical partners conform to product identification and authorization requirements under the DSCSA. Apart from saleable returns for pharmaceutical partners, VRS can provide additional verification in medical emergencies, though it’s not intended to bypass EPCIS verification.  

If you have any questions about these insights, please don’t hesitate to contact us.